Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Fukuda Denshi patient monitor model DS-8100M and DS-8100N. The Fukuda Recalled by Fukuda Denshi USA, Inc. Due to A possible malfunction where a Short-term Battery Error...

Date: December 21, 2015
Company: Fukuda Denshi USA, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Fukuda Denshi USA, Inc. directly.

Affected Products

Fukuda Denshi patient monitor model DS-8100M and DS-8100N. The Fukuda Denshi DynaScope Model DS-8100N/8100M Patient Monitor is meant to acquire and monitor physiological signals from patients.

Quantity: 95 units distributed in the US

Why Was This Recalled?

A possible malfunction where a Short-term Battery Error message has appeared and has been traced back to a bad (damaged) Lithium-Ion capacitor (Short-term Backup battery).

Where Was This Sold?

This product was distributed to 10 states: CO, ID, KS, MI, MO, OR, PA, TX, UT, WI

Affected (10 states)Not affected

About Fukuda Denshi USA, Inc.

Fukuda Denshi USA, Inc. has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report